NCT02329977 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Ando T, Tsuyuguchi T, Okugawa T, Saito M, Ishihara T, Yamaguchi T, Saisho H
Risk factors for recurrent bile duct stones after endoscopic papillotomy. Gut. 2003 Jan;52(1):116-21.
Cheon YK, Lehman GA
Identification of risk factors for stone recurrence after endoscopic treatment of bile duct stones. Eur J Gastroenterol Hepatol. 2006 May;18(5):461-4. Review.
Ishiguro J
Biliary bacteria as an indicator of the risk of recurrence of choledocholithiasis after endoscopic sphincterotomy. Diagn Ther Endosc. 1998;5(1):9-17. doi: 10.1155/DTE.5.9.
Keizman D, Ish Shalom M, Konikoff FM
Recurrent symptomatic common bile duct stones after endoscopic stone extraction in elderly patients. Gastrointest Endosc. 2006 Jul;64(1):60-5.
Kim DI, Kim MH, Lee SK, Seo DW, Choi WB, Lee SS, Park HJ, Joo YH, Yoo KS, Kim HJ, Min YI
Risk factors for recurrence of primary bile duct stones after endoscopic biliary sphincterotomy. Gastrointest Endosc. 2001 Jul;54(1):42-8. Erratum in: Gastrointest Endosc 2002 Jan;55(1):144. Chol WB [corrected to Choi WB].
Misra SP, Dwivedi M
Reflux of duodenal contents and cholangitis in patients undergoing self-expanding metal stent placement. Gastrointest Endosc. 2009 Aug;70(2):317-21. doi: 10.1016/j.gie.2008.12.054. Epub 2009 Jun 21.

Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination

Clinical trial NCT02329977 - References